(67 days)
Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder free Vinyl Patient Examination Gloves, Colored (Yellow) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided document describes the acceptance criteria and study for the HEBEI LEADER PLASTIC CO., LTD's "Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)." This is a medical device, and the evaluation focuses on its conformance to established standards for patient examination gloves.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner (as per Medical Glove Guidance Manual 1661) | Is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
| Device Description & Specifications | Meets ASTM D5250 (If vinyl: meet all current specifications listed under ASTM Specification D5250 or equivalent consensus standard) | Meets ASTM D5250 |
| Materials | PVC (If the glove is made of a polymer or other type of material, identify the material.) | PVC |
| Dusting or Donning Powder (Lubricant) | PU (If a donning lubricant is used, state the composition and include biocompatibility data for the lubricant in an identified attachment; also state the name, manufacturer, and address below) | PU (Surface Coating Agent) |
| Product Specifications | Meets ASTM D5250 standard or an equivalent standard for vinyl | Meets ASTM D5250 |
| Performance Data (Holes) | ASTM D5151 (Detection of Holes in Medical Gloves) | Meets ASTM D5151 |
| Performance Data (Residual Powder) | ASTM D6124 (Residual Powder on Medical Gloves) | Meets ASTM D6124 |
| Single Patient Use | Single Patient Use | Single Patient Use |
| Biocompatibility | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES (Meets ISO 10993-10) | SKIN IRRITATION DERMAL and SENSITIZATION STUDIES Meets ISO 10993-10 |
| Waterleak Test on Pinhole AQL | FDA requirements for waterleak test on pinhole AQL | Meets FDA requirements for waterleak test on pinhole AQL |
| General Requirements | Meets 21 CFR 800.20 | Meets 21 CFR 800.20 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., ASTM D5151, D6124, biocompatibility). However, it implies that the device "meets" these standards, which typically involve specific sampling plans and test methods outlined within the respective standard.
- Data Provenance: The manufacturing company is HEBEI LEADER PLASTIC CO., LTD, located in Shijiazhuang, China. The testing likely occurred in China, although the specific laboratories are not identified.
- Retrospective or Prospective: The testing appears to be prospective as it was conducted to demonstrate substantial equivalence for the premarket notification (510(k)) of a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable (N/A) for this device. The "ground truth" for medical gloves is established by adherence to recognized consensus standards (like ASTM and ISO) for physical properties and biocompatibility. It does not involve subjective human interpretation or diagnostic decision-making that would require expert consensus on a test set.
4. Adjudication Method for the Test Set
This is not applicable (N/A) for this device. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers evaluate data (e.g., medical images) and their disagreements need to be resolved to establish a definitive ground truth. For medical gloves, performance is measured against objective physical and chemical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices (often AI-powered) where human performance can be augmented or improved by AI assistance. This device is a patient examination glove, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance assessment was not done. This concept is applicable to AI/ML algorithms. The device being reviewed is a physical medical glove.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on recognized consensus standards (ASTM D5250, ASTM D5151, ASTM D6124) and regulatory requirements (21 CFR 800.20, ISO 10993-10 for biocompatibility). These standards define objective pass/fail criteria for the physical and chemical properties of the gloves.
8. The Sample Size for the Training Set
This is not applicable (N/A). Training sets are used for machine learning algorithms. The evaluation of this medical glove relies on physical and chemical testing against established standards, not on training an AI model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable (N/A) for the same reason as above. There is no AI training set involved.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.